1. Nanomaterial Registry: Minimal Information Standards for Well-Characterized Nanomaterials in Environmental and Biological Studies Michele L. Ostraat April 19, 2012

2. Engineering and Technology RTI International  Authoritative Web-Based Registry – Biological and environmental interactions of well- characterized nanomaterials  Broad stakeholder involvement from industry, regulatory, government, and academia  Significant Long-Term Impact – Develop new models, assays, standards, and manufacturing methods – Accelerate the translation of new nanomaterials for biomedical and environmental applications – Promote standards and support science-based regulatory decision-making Biological and Environmental Applications for Nanotechnology

3. Engineering and Technology RTI International Priorities and Features  Active program focus to Develop a minimal information standard for nanomaterials Deploy consistent vocabulary and nomenclature Develop an ontology and matching systems Address interoperability with existing and future data sets Develop evaluation criteria for consistent and validated curation Facilitate collaborations across the nanomaterial research community  Features include – Search – basic and advanced – Browse – Comparison – Matching 3

4. Engineering and Technology RTI International Leveraging & Developing Minimal Information Standards  Minimum information that must be known in order to report biological and/or environmental interactions  Challenges for Registry – Minimal information is not simply a list of physico-chemical characteristics – Sufficient information on instrumentation and methodologies used to measure characteristics must also be reported  Promote standard protocols 4

5. Engineering and Technology RTI International Example: Minimal Information and Protocols  Particle characteristics can change depending upon protocol  Report information related to characteristics and protocols 55

6. Engineering and Technology RTI International Example: Nanomaterial Morphologies 6 Zhang, J Coll Int Sci, 2(15) 2009 www.nano-lab.com Tomalia, J Nanopart Res (2009) 11 Wang, Materials Today 2004

7. Engineering and Technology RTI International Example: Size and Size Distribution  Many nanomaterials are characterized by their ensemble properties  Can change over time and in different environments 7

8. Engineering and Technology RTI International Example: Purity and Composition  As synthesized, MWCNTs contain various species – Soot – Single-walled tubes – Multi-walled tubes – Metal catalysts  Common Challenges: – How to describe and quantify – How to correlate any observed response to characteristic – Disclosure of proprietary coatings and processes 8 Multi-walled carbon nanotubes (MWCNTs) Si nanoparticles w/ surface structure

9. Engineering and Technology RTI International Minimal Information Standards for Nanomaterials Minimal Information = PCC + Measurement Details + Protocol Details Particle size Size distribution Agglomeration state Aggregation state Surface area Shape Composition Purity Surface chemistry Surface charge Surface reactivity Solubility Stability 9 Material Type Molecular Identity Density Crystallinity Crystal Structure Mean Crystallite Size Lattice Parameters Surface Coverage Level Thickness Shell Continuity Measurement Sub-Type Proportion of Nanomaterial Proportion of Core Proportion of Shell Proportion of Coating Proportion of Ligand

10. Engineering and Technology RTI International Minimal Information About Nanomaterials Particle size Size distribution Agglomeration state Aggregation state Surface area Shape Composition Purity Surface chemistry Surface charge Surface reactivity Solubility Stability 10 Size Diameter Mean diameter Mean primary particle size Mean hydrodynamic diameter Mean aerodynamic diameter Molecular weight (MW) Number Average Molecular Weight (Mn) Weight Average Molecular Weight (Mw) Volume Average Molecular Weight (Mv) Nanomaterial State Measurement Sub-Type Number Average Volume Weighted Intensity Weighted DLS Viscosity pH of Suspension Temperature of Suspension Dispersing Agent Type Purity of Dispersing Agent Concentration of Dispersing Agent Sample Concentration Medium Type Refractive Index of Medium Ionic Strength Sonication/Milling Power Sonication/Milling Time Algorithm used

11. Engineering and Technology RTI International Analytical Instrumentation Needs 11

12. Engineering and Technology RTI International Establishing Compliance Levels …functioning behind the scene Minimal Information Instrumentation Methods Parameters 12 Stage 1 Curate Data Elements Stage 2 Apply Weighting Factors Stage 3 Calculate Compliance Levels

13. Engineering and Technology RTI International Technique Details Best Practice Questions 13

14. Engineering and Technology RTI International Minimal Information Standards – Bio & Env  Biological Interactions Minimal Information includes  Categories: – In vivo – In vitro – In silico  Content: – General study details – Exposure summary – Endpoints for  Toxicity  Pharmacodynamics  Biodistribution  Biotransformation 14

15. Engineering and Technology RTI International Minimal Information Standards – Bio & Env  Environmental Interactions Minimal Information includes  Environmental Compartments: – Air – Water – Soil  Content: – General study details – Exposure summary – Endpoints for  Fate and Transport  Transformation 15

16. Engineering and Technology RTI International Thank You  Contact Information:  Michele Ostraat  919-541-5830  mostraat@rti.org 16 Engineering and Technology